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Angeion Sentinel Implantable Cardioverter Defibrillator (Icd)System and the Angeflex Tm Defibrillation Lead System.

by MicroPort CRM USA, Inc.

PMA P970024

Withdrawn Withdrawn in United States.

Was authorized under PMA, withdrawn

Ended

Withdrawn 19 Aug 1998

PMA

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPWD Approval withdrawn NumberP970024 Date19 Aug 1998Approval withdrawnStatusWithdrawn

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0802-05 FDA Unclassified (pre-2012) initiated 25 Jan 2005
    • Terminated Z-0801-05 FDA Unclassified (pre-2012) initiated 25 Jan 2005

    A change in the automatic capacitor reform schedule during the later portion of the device's useful life can result in excessive 750V charge times and disable the device's ability to report an End of Life (EOL) indicator due to excessive charge times unless the patient is receiving periodic 750V therapy shocks.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Withdrawn

Specification

PMA

Generic Name
Implantable cardioverter defibrillator (non-CRT)
PMA Number
FDA Product Code
LWS
Device Class
Class III
Advisory Committee
Cardiovascular
FDA Decision
APWD Approval withdrawn

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